EU commission issues an updated planning for gradual roll out of the EUDAMED modules, however, the timeline for delivery of the clinical investigations / performance studies module has been set yet. In other words we are still stuck with local approaches when it comes to adverse event reporting to the regulatory bodies involved in clinical […]
Lees meerHow do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]
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